NCT02968732

Brief Summary

A prospective, investigational study to assess the accuracy of standardized cystoscopic evaluation with tissue sampling performed immediately prior to definitive radical cystectomy to predict pathologic tumor stage and identify patients who may benefit from bladder preservation therapy.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Nov 2016Apr 2027

First Submitted

Initial submission to the registry

November 10, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

November 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2019

Completed
7.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

2.8 years

First QC Date

November 10, 2016

Last Update Submit

July 2, 2025

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

  • To evaluate the accuracy of endoscopic assessment in predicting pT0 urothelial disease in the urinary bladder at the time of radical cystectomy.

    Endoscopic assessments will be performed using a novel scoring system that allows objective quantification of endoscopic findings at the time of cystoscopy. The findings will be compared to final pathological specimen to determine reliability of predicting pTO disease from endoscopic assessment

    30 days post surgery

Secondary Outcomes (3)

  • To determine if genomic tumor signatures from pre-treatment tumor tissue can predict chemotherapy response.

    up to 5years post surgery

  • To determine how genomic tumor signatures compare before and after chemotherapy administration.

    up to 5years post surgery

  • To determine if genomic signature from tissue obtained on endoscopic evaluation just prior to cystectomy can help predict final pathological stage.

    up to 5years post surgery

Study Arms (1)

Surgical

EXPERIMENTAL
Procedure: Radical Cystectomy

Interventions

Radical CystectomyPROCEDURE
Surgical

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients age \>18 years at the time of consent.
  • Patients with a diagnosis of urothelial carcinoma clinical stage T1-T4NanyM0.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
  • Patients must have a clinical decision to proceed with radical cystectomy by any conventional approach (open, laparoscopic, robot-assisted laparoscopic). Time from decision to surgery is usually 3-8 weeks for those who do not receive neoadjuvant chemotherapy and 10-14 weeks for those who receive neo-adjuvant chemotherapy treatment. During this time, eligibility for study participation will be verified.
  • Ability to understand and willingness to sign a written informed consent and HIPAA authorization document or a legally authorized representative who has the ability to understand and willingness to sign a written informed consent and HIPAA authorization on behalf of the participant.
  • Women of reproductive potential must have agreed to use an effective contraceptive measure.

You may not qualify if:

  • Patients who undergo cystectomy with non-curative intent will be excluded.
  • Patients who have undergone any prior pelvic irradiation.
  • Patients who are pregnant or nursing. Radical cystectomy and prolonged general anesthesia would place the fetus at considerable risk of demise. The prolonged recovery and debility of the patient would severely limit the patient's ability to nurse and care for an infant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

  • Satyal U, Valentine H, Liu D, Slifker M, Lallas CD, Trabulsi EJ, Bukavina L, Szeto L, Hoffman-Censits JH, Mouw KW, Faltas BM, Grivas P, Ibragimova I, Porten SP, Van Allen EM, Geynisman DM, Parker DC, O'Neill JP, Drevik J, Christianson SS, Ginzburg S, Correa AF, Uzzo RG, Ross EA, Zibelman MR, Ghatalia P, Plimack ER, Kutikov A, Abbosh PH. Urine Biopsy as Dynamic Biomarker to Enhance Clinical Staging of Bladder Cancer in Radical Cystectomy Candidates. JCO Precis Oncol. 2024 Jun;8:e2300362. doi: 10.1200/PO.23.00362.

    PMID: 38865671DERIVED

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Alexander Kutikov, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 21, 2016

Study Start

November 11, 2016

Primary Completion

August 19, 2019

Study Completion (Estimated)

April 1, 2027

Last Updated

July 4, 2025

Record last verified: 2025-07

Locations

US(1)